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- GMP compliant Products CertiPro
GMP compliant Products CertiPro
FUJIFILM Wako Pure Chemical provides pharmaceutical raw materials that can be used in the manufacturing process of pharmaceutical products. CertiPro is a series of pharmaceutical products, which is manufactured under GMP.
Pharmaceutical Raw Materials
GMP compliant Products CertiPro
Pharmaceutical raw materials manufactured under GMP management. The lineup includes products listed in the Japanese Pharmacopoeia (JP), Japanese Pharmaceutical Codex (JPC), and Japanese Pharmaceutical Excipients (JPE).
Features
- ・GMP compliant.
- ・Products listed in the JP, JPC, and JPE
- ・Conforming to the specifications in the USP-NF and Ph. Eur. (depending on the product)
These products are classified into two categories depending on compliant standards: CertiPro (GMP compliant products) and CertiPro-L (ISO9001 compliant products).
CertiPro
Features
- ・GMP compliant
- ・Products listed in the JP, JPC, and JPE*1
- ・Conforming to the specifications in the USP and Ph. Eur. (depending on the product)*2
*1 Information such as ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities) can be obtained from “Statement”. Please contact us for more details.
*2 Specification of products reflects latest versions of pharmacopeia.
CertiPro Product Lineup
Click here for an explanation of our statement on pharmaceutical raw materials
Please contact us for individual requests regarding capacity.
Product Name | CAS RN® | Grade | Conformity | Endotoxin | Package Size | Product Code | Principal Use | Statement | |
USP-NF | Ph.Eur. | ||||||||
Acetylcysteine | 616-91-1 | JP | ✓ | ✓ | Less than 10EU/g | 10 kg | 013-28757 | Culture medium additive | EN |
---|---|---|---|---|---|---|---|---|---|
Calcium Chloride Hydrate | 10035-04-8 | JP | Less than 2.5EU/g | 500 g | 030-19555 | Stabilizer | EN | ||
Calcium Gluconate Hydrate | 299-28-5 | JP | Less than 1.5EU/g | 500 g | 037-26035 | Calcium strengthener | EN | ||
10 kg | 033-26037 | ||||||||
Citric Acid Hydrate | 5949-29-1 | JP | ✓ | ✓ | Less than 8EU/g | 500 g | 032-25245 | Stabilizer・ Buffer |
EN |
Dibasic Potassium Phosphate | 7758-11-4 | JPC | ー | 500 g | 047-29015 | Buffer | EN | ||
20 kg | 043-29017 | ||||||||
Dibasic Sodium Phosphate Hydrate | 10039-32-4 | JP | ✓ | ✓ | Less than 0.2EU/g | 500 g | 047-34385 | Buffer | EN |
10 kg | 043-34387 | ||||||||
Disodium Edetate Hydrate | 6381-92-6 | JP | Less than 10EU/g | 500 g | 046-34615 | Stabilizer | EN | ||
20 kg | 042-34617 | ||||||||
Dried Sodium Carbonate | 497-19-8 | JP | Less than 10EU/g | 500 g | 049-34345 | Buffer | EN | ||
10 kg | 045-34347 | ||||||||
Glucose | 50-99-7 | JP | ー | 500 g | 076-05705 | Stabilizer | EN | ||
10 kg | 072-05707 | ||||||||
Glycine | 56-40-6 | JP | ✓ | ✓ | Less than 1.2EU/g | 500 g | 075-06875 | Stabilizer | EN |
Hydrochloric Acid | 7647-01-0 | JP | ✓ | Less than 10EU/g | 500 mL | 082-10475 | Stabilizer・ Buffer |
EN | |
Lactose Hydrate | 64044-51-5 | JP | *3 | Less than 25EU/g | 500 g | 121-06685 | Excipients | EN | |
Magnesium Sulfate Hydrate | 10034-99-8 | JP | Less than 10EU/g | 500 g | 130-18925 | Stabilizer | EN | ||
D-Mannitol | 69-65-8 | JP | *3 | Less than 2.5EU/g | 500 g | 133-14495 | Stabilizer | EN | |
Monobasic Potassium Phosphate | 7778-77-0 | JPC | ー | 500 g | 136-14485 | Buffer | EN | ||
25 kg | 132-14487 | ||||||||
Potassium Chloride | 7447-40-7 | JP | ー | 500 g | 163-22105 | Buffer | EN | ||
Potassium Iodide | 7681-11-0 | JP | ー | 500 g | 161-21925 | Stabilizer・ Soluble agent |
EN | ||
Purified Glucose | 50-99-7 | JP | *3 | Less than 2EU/g | 500 g | 168-28515 | Stabilizer | EN | |
10 kg | 164-28517 | ||||||||
Sodium Acetate Hydrate | 6131-90-4 | JP | Less than 2.5EU/g | 500 g | 197-13235 | Buffer | EN | ||
Sodium Bicarbonate | 144-55-8 | JP | ✓ | Less than 10EU/g | 500 g | 197-18475 | Buffer | EN | |
10 kg | 193-18477 | ||||||||
Sodium Chloride | 7647-14-5 | JP | ✓ | ✓ | Less than 3.1EU/g | 500 g | 194-18505 | Stabilizer・ Buffer |
EN |
10 kg | 190-18507 | ||||||||
Sodium Citrate Hydrate | 6132-04-3 | JP | ✓ | ✓ | Less than 5.2EU/g | 500 g | 197-18855 | Stabilizer・ Buffer |
EN |
10 kg | 193-18857 | ||||||||
Sodium Dihydrogen Phosphate Dihydrate | 13472-35-0 | JPE | ✓ | ✓ | Less than 2.0EU/g | 500 g | 191-18495 | Buffer | EN |
10kg | 197-18497 | ||||||||
Sodium L-Glutamate Hydrate | 6106-04-3 | JPC | (NF) | ―*4 | Less than 3.9EU/g | 500 g | 135-15555 | Stabilizer・ Buffer |
EN |
20 kg | 131-15557 | ||||||||
Sodium Hydroxide | 1310-73-2 | JP | (NF) | ✓ | Less than 10EU/g | 500 g | 190-18465 | Buffer | EN |
10 kg | 196-18467 | ||||||||
Sodium Thiosulfate Hydrate | 10102-17-7 | JP | Less than 10EU/g | 500 g | 196-19165 | Stabilizer・ Solubilizer |
EN | ||
20 kg | 192-19167 | ||||||||
Sucrose | 57-50-1 | JP | (NF) | ✓ | Less than 2EU/g | 500 g | 198-18385 | Stabilizer | EN |
10 kg | 194-18387 | ||||||||
Sucrose [Low endotoxin type (Less than 0.2EU/g)] | 57-50-1 | JP | (NF) | ✓ | Less than 0.2EU/g | 500 g | 197-19195 | Stabilizer | EN |
10 kg | 193-19197 | ||||||||
Trometamol | 77-86-1 | JPC | ✓ | ✓ | Less than 0.03IU/g | 500 g | 203-21035 | Buffer | EN |
10 kg | 209-21037 | ||||||||
Urea | 57-13-6 | JP | Less than 2.5EU/g | 500 g | 213-01295 | Stabilizer | EN |
*3 These products are tested according to JP method. Some of the test items are harmonized to USP-NF Ph.Eur. For details, please check the product specifications.
*4 This product is not listed in Ph.Eur.